announcing that it had found decades-old vials of variola—the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month." />

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola—the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month.

Dangerous Substances

In a statement released to the press on 16 July 2014, the agency confirmed that it found hundreds—327 to be exact— of "carefully packaged vials" containing "various biological agents."

But those agents were cause for significant concern, regulators said. The vials contained samples of dengue, influenza, Q fever and rickettsia, FDA confirmed. All diseases confirmed by FDA are known to be fatal, though none rise to the same level of concern as the variola virus.

The agency did not provide a complete accounting of the findings, saying only that they had all been transferred to "the appropriate NIH safety program officials, who in turn transferred them to the appropriate investigative agencies, as per standard protocols."

"While an investigation continues regarding the origin of these samples, this collection was most likely assembled between 1946 and 1964 when standards for work with and storage of biological specimens were very different from those used today," FDA said in a statement. "All of the items labeled as infectious agents found in the collection of samples were stored in glass, heat-sealed vials that were well-packed, intact, and free of any leakage, and there is no evidence that anyone was exposed to these agents."

Troubling Questions, Changes Coming

The discovery of the vials nevertheless raises troubling questions about whether other specimens could be present in other FDA facilities. Regulators acknowledged this potential, saying they have already initiated a review of other common cold storage spaces, and that FDA is also "reviewing its policies and procedures in order to implement a corrective action plan so that potentially hazardous samples are never overlooked in the future."

At the core of those corrective efforts may well be changes in the way FDA treats its common storage areas. A former high-ranking FDA official told Focus the Center for Biologics Evaluation and Research's (CBER)—the Center which controlled the facility where the biological agents were found—storage procedures were "chaotic," with "little oversight" in the shared freezers and freezer rooms "except when there was a freezer failure."